GRISEOFULVIN (griseofulvin- microsize suspension

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

GRISEOFULVIN (UNII: 32HRV3E3D5) (GRISEOFULVIN - UNII:32HRV3E3D5)

Saadav alates:

Chartwell RX, LLC.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Major indications for Griseofulvin Oral Suspension, USP are: Tinea capitis (ringworm of the scalp) Tinea corporis (ringworm of the body) Tinea pedis (athlete's foot) Tinea unguium (onychomycosis; ringworm of the nails) Tinea cruris (ringworm of the thigh) Tinea barbae (barber’s itch) Griseofulvin Oral Suspension, USP inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as: Trichophyton rubrum Trichophyton tonsurans Trichophyton mentagrophytes Trichophyton interdigitalis Trichophyton verrucosum Trichophyton sulphureum Trichophyton schoenleini Microsporum audouini Microsporum canis Microsporum gypseum Epidermophyton floccosum Trichophyton megnini Trichophyton gallinae Trichophyton crateriform Note: Prior to ther

Toote kokkuvõte:

Griseofulvin Oral Suspension, USP (microsize) 125 mg per 5 mL is available as follows: 4 fl oz (120 mL) bottle (NDC 62135-968-41) Dispense Griseofulvin Oral Suspension, USP in a tight, light-resistant container as defined in the USP. STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Chartwell Pharmaceuticals, LLC. Congers, NY 10920 Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L70567        Rev: 08/2021

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

GRISEOFULVIN- GRISEOFULVIN (MICROSIZE) SUSPENSION
CHARTWELL RX, LLC.
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GRISEOFULVIN ORAL SUSPENSION, USP (MICROSIZE)
125 MG/5 ML
RX ONLY
DESCRIPTION
Griseofulvin is an antibiotic derived from a species of _Penicillium._
Each 5 mL of
Griseofulvin Oral Suspension, USP contains 125 mg of griseofulvin
(microsize) and also
contains alcohol (0.2%), docusate sodium, FD&C Red No. 40, FD&C Yellow
No. 6,
magnesium aluminum silicate, menthol, methylparaben, orange cream
flavors, propylene
glycol, propylparaben, purified water, saccharin sodium, simethicone
emulsion, sodium
alginate and sucrose.
CLINICAL PHARMACOLOGY
Griseofulvin Oral Suspension, USP acts systemically to inhibit the
growth of
_Trichophyton, Microsporum, _and _Epidermophyton _genera of fungi.
Fungistatic amounts
are deposited in the keratin, which is gradually exfoliated and
replaced by noninfected
tissue.
Griseofulvin absorption from the gastrointestinal tract varies
considerably among
individuals, mainly because of insolubility of the drug in aqueous
media of the upper G.I.
tract. The peak serum level found in fasting adults given 0.5 gm
occurs at about four
hours and ranges between 0.5 and 2.0 mcg/mL.
It should be noted that some individuals are consistently "poor
absorbers" and tend to
attain lower blood levels at all times. This may explain
unsatisfactory therapeutic results
in some patients. Better blood levels can probably be attained in most
patients if
griseofulvin is administered after a meal with a high fat content.
INDICATIONS AND USAGE
Major indications for Griseofulvin Oral Suspension, USP are:
Tinea capitis (ringworm of the scalp)
Tinea corporis (ringworm of the body)
Tinea pedis (athlete's foot)
Tinea unguium (onychomycosis; ringworm of the nails)
Tinea cruris (ringworm of the thigh)
Tinea barbae (barber’s itch)
Griseofulvin Oral Suspension, USP inhibits the growth of those genera
of fungi that
commonly cause ringworm infections of the hair, skin, and nails, such
as:
_Trichophyton rubrum_
_Trichophyton tonsurans_
_Trichophyton menta